The following data is part of a premarket notification filed by Icor Ab with the FDA for Icor Calaric Measurement Unit (cmu).
| Device ID | K854927 |
| 510k Number | K854927 |
| Device Name: | ICOR CALARIC MEASUREMENT UNIT (CMU) |
| Classification | Computer, Oxygen-uptake |
| Applicant | ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30 |
| Contact | Gedeon, Ph.d. |
| Correspondent | Gedeon, Ph.d. ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-10 |
| Decision Date | 1986-03-27 |